Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease

Phase 2

Completed

• Conditions: Crohn Disease
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01233570
• Lead Sponsor: University of Aberdeen

Brief Summary

An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Last Update Submitted: 2010-11-02
• Study First Posted: 2010-11-03
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• willingness and capability to follow the study procedure
• confirmed diagnosis of Crohn's Disease of at least 3 months duration confirmed by radiography, endoscopy or pathological examination
• required to have a skin manifestation of Crohn's disease
• required to give written informed consent
• both male and female subjects with reproductive potential required to be on an acceptable form of birth control for the duration of the study
• long-standing, concomitant immunosuppressive therapy was allowed if the dose was stable and not controlling the skin problem

Exclusion Criteria

• known sensitivity to tacrolimus
• change in aminosalicylate dosage in the four weeks prior to screening
• on oral steroids at over 40mg per day
• been commenced on methotrexate, azathoprine or ciclosporin within the last two months
• commenced on a a TNF-alpha monoclonal antibody within the three months prior to screening
• patients having had a stoma fashioned less than three months before enrolment
• patients with an immunocompromising disease
• patients with a diagnosis of malignancy within the last five years
• patients with any other condition, past or present treatment thought by the investigator to render the subject ineligible for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical tacrolimus	Tacrolimus	Once daily topical application

Primary Outcome Measures

Name	Time	Method
Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment	At 12 weeks of treatment, optionally extended to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Global Self Assessment	12 weeks, optionally extended to 52 weeks
Perineal Disease Activity Index	12 weeks, optionally extended to 52 weeks

Trial Locations

Locations (1)

University of Aberdeen, Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, Grampian, United Kingdom